HYDROCODONE/APAP tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D), HYDROCODONE BITARTRATE (UNII: NO70W886KK) (HYDROCODONE - UNII:6YKS4Y3WQ7)

Available from:

Direct_Rx

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Hydrocodone bitartrate and acetaminophen tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses (see WARNINGS), reserve hydrocodone bitartrate and acetaminophen tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics): have not been tolerated, or are not expected to be tolerated, have not provided adequate analgesia, or are not expected to provide adequate analgesia Hydrocodone bitartrate and acetaminophen tablets are contraindicated in patients with: Significant respiratory depression (see WARNINGS) Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment (see WARNINGS) Known or suspected gastrointestinal obstruction, including paralytic ileus (see WARNINGS) Hypersensitivity to hydrocodone or acetaminophen (e.g., ana

Product summary:

Hydrocodone Bitartrate and Acetaminophen Tablets USP are supplied as follows: Strength How Supplied Each tablet contains: Description of tablet Hydrocodone Bitartrate Acetaminophen 5 mg/325 mg Bottles of 60 …………..… NDC 72189-407-60 Bottles of 90 …………..… NDC 72189-407-90 Unit Dose (10 x 10) …….. NDC 0406-0123-62 5 mg 325 mg It is available as a capsule-shaped white tablet debossed with M365 on one side and bisected on the other side. 7.5 mg/325 mg Bottles of 20 …………..… NDC 0406-0124-20 Bottles of 30 …………..… NDC 0406-0124-30 Bottles of 60 …………..… NDC 0406-0124-60 Bottles of 90 …………..… NDC 0406-0124-90 Bottles of 100 …………… NDC 0406-0124-01 Bottles of 120 ..………..… NDC 0406-0124-12 Bottles of 500 …………… NDC 0406-0124-05 Bottles of 1000 ………..… NDC 0406-0124-10 It is available as an unscored oval-shaped white tablet debossed with M366 on one side. 10 mg/325 mg Bottles of 20 …………..… NDC 0406-0125-20 Bottles of 30 …………..… NDC 0406-0125-30 Bottles of 60 …………..… NDC 0406-0125-60 Bottles of 90 …………..… NDC 0406-0125-90 Bottles of 100 …………… NDC 0406-0125-01 Bottles of 120 ..………..… NDC 0406-0125-12 Bottles of 500 …………… NDC 0406-0125-05 Bottles of 1000 ………..… NDC 0406-0125-10 Unit Dose (10 x 10) …….. NDC 0406-0125-62 10 mg 325 mg It is available as a capsule-shaped white tablet debossed with M367 on one side and bisected on the other side. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light. Dispense in a tight, light-resistant container (as defined in USP) with a child-resistant closure. Store hydrocodone bitartrate and acetaminophen tablets securely and dispose of properly (see PRECAUTIONS, INFORMATION FOR PATIENTS). Mallinckrodt, the “M” brand mark and the Mallinckrodt Pharmaceuticals logo are trademarks of a Mallinckrodt company. © 2020 Mallinckrodt. SpecGx LLC Webster Groves, MO 63119 USA Rev 08/2020 Mallinckrodt™ Pharmaceuticals An electronic copy of this medication guide can be obtained from www.mallinckrodt.com/Medguide/MG20H32.pdf or by calling 1-800-778-7898 for alternate delivery options.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

HYDROCODONE/APAP- HYDROCODONE/APAP TABLET
Direct_Rx
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Medication Guide
Hydrocodone Bitartrate (hye” droe koe’ done bye tar’ trate) and
Acetaminophen (a seet” a min’ oh fen)
Tablets CII
Hydrocodone bitartrate and acetaminophen tablets are:
A strong prescription pain medicine that contains an opioid (narcotic)
that is used to manage pain severe
enough to require an opioid pain medicine, when other pain treatments
such as non-opioid pain medicines
do not treat your pain well enough or you cannot tolerate them.
An opioid pain medicine that can put you at risk for overdose and
death. Even if you take your dose
correctly as prescribed you are at risk for opioid addiction, abuse,
and misuse that can lead to death.
Important information about hydrocodone bitartrate and acetaminophen
tablets:
Get emergency help or call 911 right away if you take too many
hydrocodone bitartrate and
acetaminophen tablets (overdose). When you first start taking
hydrocodone bitartrate and acetaminophen
tablets, when your dose is changed, or if you take too many
(overdose), serious or life-threatening
breathing problems that can lead to death may occur. Talk to your
healthcare provider about naloxone, a
medicine for the emergency treatment of an opioid overdose.
Taking hydrocodone bitartrate and acetaminophen tablets with other
opioid medicines, benzodiazepines,
alcohol, or other central nervous system depressants (including street
drugs) can cause severe drowsiness,
decreased awareness, breathing problems, coma, and death.
Never give anyone else your hydrocodone bitartrate and acetaminophen
tablets. They could die from
taking it. Selling or giving away hydrocodone bitartrate and
acetaminophen tablets is against the law.
Store hydrocodone bitartrate and acetaminophen tablets securely, out
of sight and reach of children, and
in a location not accessible by others, including visitors to the
home.
Do not take hydrocodone bitartrate and acetaminophen tablets if you
have:
severe asthma, trouble breathing, or other lung problems.

Summary of Product characteristics

HYDROCODONE/APAP- HYDROCODONE/APAP TABLET
DIRECT_RX
----------
HYDROCODONE/APAP
WARNING: ADDICTION, ABUSE, AND MISUSE; RISK EVALUATION AND MITIGATION
STRATEGY (REMS); LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL
INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; CYTOCHROME P450
3A4 INTERACTION; HEPATOTOXICITY; and RISKS FROM CONCOMITANT USE WITH
BENZODIAZEPINES OR OTHER CNS DEPRESSANTS
Addiction, Abuse, and Misuse
Hydrocodone bitartrate and acetaminophen tablets expose patients and
other
users to the risks of opioid addiction, abuse, and misuse, which can
lead to
overdose and death. Assess each patient’s risk prior to prescribing
hydrocodone
bitartrate and acetaminophen tablets, and monitor all patients
regularly for the
development of these behaviors and conditions (see WARNINGS).
Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS):
To ensure that the benefits of opioid analgesics outweigh the risks of
addiction,
abuse, and misuse, the Food and Drug Administration (FDA) has required
a REMS
for these products (see WARNINGS). Under the requirements of the REMS,
drug
companies with approved opioid analgesic products must make
REMS-compliant
education programs available to healthcare providers. Healthcare
providers are
strongly encouraged to
complete a REMS-compliant education program,
counsel patients and/or their caregivers, with every prescription, on
safe use,
serious risks, storage, and disposal of these products,
emphasize to patients and their caregivers the importance of reading
the
Medication Guide every time it is provided by their pharmacist, and
consider other tools to improve patient, household, and community
safety.
Life-Threatening Respiratory Depression
Serious, life-threatening, or fatal respiratory depression may occur
with use of
hydrocodone bitartrate and acetaminophen tablets. Monitor for
respiratory
depression, especially during initiation of hydrocodone bitartrate and
acetaminophen tablets or following a dose increase (see WARNINGS).
Accidental Ingestion
Accidental ingestion